Catheter Assembly With Guidewire, Catheter and Puncture Needle

ABSTRACT

A catheter assembly includes a catheter, a catheter hub fixed to the proximal end of the catheter, a needle positioned inside the catheter, a gripping member connected to a proximal portion of the inner needle, a catheter operating member connected to the catheter hub and movable in the longitudinal direction relative to the inner needle, a guide wire slidably positioned in the inner needle and possessing a length longer than both the inner needle and the catheter, and a wire operating member connected to the guide wire so that movement of the wire operating member results in movement of the guide wire. The catheter operating member is configured to press a portion of the catheter between the proximal end of the catheter and the distal end of the catheter when the user presses on the catheter operating member while puncturing a living body with the needlepoint.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/941,632 filed on Mar. 30, 2018, which is a continuation of U.S.application Ser. No. 15/083,965 filed on Mar. 29, 2016, which is acontinuation of U.S. application Ser. No. 14/960,484 filed on Dec. 7,2015, which is a continuation of International Application No.PCT/JP2014/058490 filed on Mar. 26, 2014, and claims priority toJapanese Application No. 2013-123465 filed on Jun. 12, 2013, the entirecontent of all of which is incorporated herein by reference.

TECHNICAL FIELD

The present invention generally relates to a catheter assembly adaptedto puncture a blood vessel and indwelled at the time of performinginfusion to a patient, for example.

BACKGROUND DISCUSSION

A catheter assembly is used at the time of performing infusion to apatient or the like. This kind of catheter assembly includes a hollowouter needle (catheter), an outer needle hub (catheter hub) fixed to aproximal end of the outer needle, an inner needle inserted into theouter needle and having a sharp needlepoint at a distal end, and aninner needle hub fixed to a proximal end of the inner needle. In thecase of performing infusion to the patient by using the catheterassembly, a blood vessel of the patient is punctured with the outerneedle together with the inner needle. After puncturing, the innerneedle is pulled out from the outer needle while keeping the patientpunctured with the outer needle. Next, a connector provided at an endportion of an infusion tube is connected to a proximal end of the outerneedle hub, and infusion material is supplied into the blood vessel ofthe patient via the infusion tube, outer needle hub, and outer needle.An example of such a catheter assembly used as a peripheral intravenouscatheter is disclosed in Japanese Patent No. 5108882.

A central intravenous catheter, a peripherally inserted central catheter(PICC), a midline catheter, etc. are known as catheters having a lengthlonger than the peripheral intravenous catheter, indwelled inside ablood vessel of a patient, and used to administer infusion solution.Therefore, when respective lengths of the inner needle and the catheterof the catheter assembly are long, it is possible to use as the centralintravenous catheter, PICC, midline catheter, etc.

SUMMARY

However, when the lengths of an inner needle and a catheter arerelatively long, puncturing is difficult because the inner needle andthe catheter may be deflected at the time of a puncturing operation.Further, when there are meandering and branching in a blood vessel,insertion is difficult at the time of inserting the catheter up to apredetermined position inside the blood vessel.

A catheter assembly is disclosed here to relatively easily perform thepuncturing operation even in the case where the lengths of the innerneedle and the catheter are relatively long, and further configured torather easily insert the catheter into the blood vessel.

According to one aspect, a catheter assembly comprises: a catheterpossessing a distal end, a proximal end and a proximal end portion; acatheter hub fixed to the proximal end portion of the catheter, andpossessing a proximal-most end; a hollow inner needle positioned insidethe catheter and removable from inside the catheter, with the needlepossessing a distal end and including a needlepoint at the distal end ofthe needle; a gripping member connected to a proximal portion of theinner needle and extending in a longitudinal direction; and a catheteroperating member connected to the catheter hub and movable in thelongitudinal direction relative to the inner needle, wherein thecatheter operating member includes an operating portion. The operatingportion of the catheter operating member possesses a part to which aforce is applied by a user to move the catheter relative to the innerneedle from a position in which a distal-most end of the catheter ispositioned proximal to the needlepoint to a position in which thedistal-most end of the catheter is positioned distal to the needlepoint.A guide wire is slidably positioned in the inner needle and possesses adistal end, with the guide wire possessing a length longer than theinner needle and longer than the catheter, and with the guide wire beingconfigured so that the distal end of the guide wire projects distallybeyond the needlepoint during use of the catheter assembly. A wireoperating member is connected to the guide wire so that movement of thewire operating member results in movement of the guide wire. The wireoperating member is movable in the longitudinal direction relative tothe inner needle and the catheter, and the wire operating memberincludes an operating portion. The wire operating member that movestogether with the guide wire possesses a distal-most end that axiallyoverlaps a part of the catheter operating member when the distal-mostend of the catheter is positioned proximal of the needlepoint before useof the catheter assembly. The operating portion of the wire operatingmember possesses a part to which a force is applied by the user to movethe guide wire relative to the catheter and the inner needle. Thecatheter operating member is configured to press a portion of thecatheter between the proximal end of the catheter and the distal end ofthe catheter when the user presses on the catheter operating memberwhile puncturing a living body with the needlepoint.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view illustrating a catheter assembly accordingto a first embodiment disclosed here.

FIG. 2 is an exploded perspective view illustrating the catheterassembly illustrated in FIG. 1.

FIG. 3 is a partly-omitted vertical cross-sectional view illustratingthe catheter assembly illustrated in FIG. 1.

FIG. 4A is a perspective view illustrating a catheter hub in thecatheter assembly illustrated in FIG. 1, and FIG. 4B is a perspectiveview illustrating a proximal end side of a pressing member in thecatheter assembly illustrated in FIG. 1.

FIG. 5 is a first view illustrating a using method of the catheterassembly illustrated in FIG. 1.

FIG. 6 is a second view illustrating the using method of the catheterassembly illustrated in FIG. 1.

FIG. 7 is a third view illustrating the using method of the catheterassembly illustrated in FIG. 1.

FIG. 8 is a fourth view illustrating the using method of the catheterassembly illustrated in FIG. 1.

FIG. 9 is a fifth view illustrating the using method for the catheterassembly illustrated in FIG. 1.

FIG. 10 is a perspective view illustrating a catheter assembly accordingto a second embodiment disclosed here.

FIG. 11 is an exploded perspective view illustrating the catheterassembly illustrated in FIG. 10.

FIG. 12 is a partly-omitted vertical cross-sectional view illustratingthe catheter assembly illustrated in FIG. 10.

FIG. 13 is a first view illustrating the using method of the catheterassembly illustrated in FIG. 10.

FIG. 14 is a second view illustrating the using method of the catheterassembly illustrated in FIG. 10.

FIG. 15 is a third view illustrating the using method of the catheterassembly illustrated in FIG. 10.

FIG. 16 is a fourth view illustrating the using method of the catheterassembly illustrated in FIG. 10.

FIG. 17 is a fifth view illustrating the using method of the catheterassembly illustrated in FIG. 10.

FIG. 18 is a sixth view illustrating the using method of the catheterassembly illustrated in FIG. 10.

DETAILED DESCRIPTION

Set forth below, with reference to the accompanying drawing figures, isa detailed description of embodiments of a catheter assemblyrepresenting examples of the inventive catheter assembly disclosed here.

FIGS. 1-3 illustrate an example of the inventive a catheter assembly 10Adisclosed here according to a first embodiment.

The catheter assembly 10A is gripped and operated by a user (doctor,nurse, etc.) in an initial state illustrated in FIG. 1, and a bloodvessel of a patient is punctured with a distal end of the catheterassembly 10A. Then, predetermined respective operations are performed,and only a catheter member 15 adapted to puncture the blood vessel andinserted into the blood vessel is indwelled on the patient's side.Further, a connector of an infusion tube (not illustrated) is connectedto a proximal end portion of the catheter member 15, thereby supplyinginfusion material (chemical solution) to the patient from the infusiontube. Set forth next is a detailed description of the structure of thecatheter assembly 10A.

The catheter assembly 10A includes a catheter 12, a catheter hub 14connected to the catheter 12, an inner needle 16 inserted into orpositioned inside the catheter 12, a pressing member 18 connected to thecatheter hub 14, a guide wire 20 inserted into or positioned inside theinner needle 16, a wire operating member 22 connected to the guide wire20, and a gripping member 24 connected to the inner needle 16.

The catheter 12 functions as an outer needle, and is a flexible tubularmember formed to have a predetermined length and a relatively smalldiameter. The catheter assembly 10A has a double tube structure in whichthe inner needle 16 is inserted into or positioned inside the catheter12 in the initial state before use (before puncturing the patient), andthe inner needle 16 projects distally beyond a distal end of thecatheter 12 by a predetermined length. In the following description, theinitial state of the catheter assembly 10A may also be referred to as an“assembled state”. Inside the catheter 12, a lumen 13 extending in anaxial direction is formed and penetrates the inside of the catheter 12.The inner diameter of the lumen 13 is set to a size permitting the innerneedle 16 to be inserted into the lumen 13 of the catheter 12.

A constituent material of the catheter 12 (i.e., the material from whichthe catheter 12 is made) is resin material, and particularly a flexibleresin material is preferable. In this case, specific examples mayinclude fluororesins such as polytetrafluoroethylene (PTFE),ethylene-tetrafluoroethylene copolymer (ETFE), perfluoroalkoxyfluororesin (PFA), olefin resins such as polyethylene and polypropylene,or mixtures thereof, polyurethane, polyesters, polyamides, polyethernylon resins, and mixtures of the olefin resin and ethylene-vinylacetate copolymer, and the like.

The catheter 12 may be formed of a clear resin such that the entirety ofthe inside of the catheter 12, or a part of the inside of the catheter12, can be visually checked or observed. The catheter 12 may includeradiopaque (opaque to X-ray) material (such as barium monoxide) to havean imaging function.

A length of the catheter 12 is not particularly limited and suitably isset in accordance with a purpose of use, other conditions, and so on.For example, the length of the catheter 12 is about 20 to 500 mm,preferably about 30 to 400 mm, and more preferably about 100 to 300 mm.

The catheter 12 may be used as, for example, a catheter having thelength longer than a peripheral intravenous catheter such as a centralintravenous catheter, a PICC, or a midline catheter. The catheter 12 mayalso be used as the peripheral intravenous catheter.

As illustrated in FIG. 3, the catheter hub 14 is liquid-tightlyconnected and fixed to the proximal end of the catheter 12. Specificexamples of a means to fix the catheter hub 14 to the catheter 12include crimping, fusion (heat-fusion, high-frequency fusion, etc.),adhesion by an adhesive, etc. The catheter hub 14 is configured as atube having a taper shape. The catheter member 15 is formed by joiningthe catheter 12 with the catheter hub 14.

The constituent material forming the catheter hub 14 is not particularlylimited, but various kinds of resin materials may be used, for example,polyolefins such as polyethylene, polypropylene, and ethylene-vinylacetate copolymer, polyurethane, polyamides, polyester, polycarbonate,polybutadiene, polyvinyl chloride, polyacetal, and so on.

At the time of using the catheter assembly 10A, the catheter hub 14 isexposed or positioned on the skin of the patient in a state that theblood vessel is punctured with the catheter 12, and the catheter hub 14is pasted or held on the skin by using tape or the like for indwelling.Preferably, the catheter hub 14 is formed of material harder than thecatheter 12. The constituent material for fabricating the catheter hub14 is not particularly limited, but specific examples may preferablyinclude thermoplastic resins such as polypropylene, polycarbonate,polyamides, polyether sulfone, polyarylate, andmethacrylate-butyrene-styrene copolymer.

The inner needle 16 is a hollow member including a distal end opening, aproximal end opening, and a lumen 17 extending between the distal endopening and the proximal end opening. Further, the inner needle 16includes a sharp needlepoint 16 a at a distal end of the inner needle16. The inner needle 16 has a length longer than the catheter 12. Whenthe catheter assembly 10A is in the assembled state, the needlepoint 16a projects distally beyond the distal end opening of the catheter 12,and a proximal end of the inner needle 16 projects proximally beyond theproximal end portion of the catheter member 15 (catheter hub 14).Further, in the assembled state, a middle portion in the longitudinaldirection of the inner needle 16 is inserted into or positioned insidethe catheter hub 14.

The inner needle 16 has rigidity allowing the inner needle 16 topuncture the skin of the patient. Specific examples of a constituentmaterial for fabricating the inner needle 16 may include metallicmaterials such as stainless steel, aluminum or an aluminum alloy, ortitanium or a titanium alloy.

The pressing member 18 is connected to the catheter hub 14, and, in theassembled state, is configured to press a portion between the proximalend and the distal end of the catheter 12 (middle portion orintermediate portion in the longitudinal direction of the catheter 12)at the time of performing a puncturing operation to puncture the bloodvessel with the needlepoint 16 a of the inner needle 16 and the distalend portion of the catheter 12. More specifically, the pressing member18 includes a pressing portion 26 configured to press the portion of thecatheter 12 between the proximal end of the catheter 12 and the distalend of the catheter 12. The pressing portion 26 is a component toprevent the inner needle 16 and the catheter 12 from being deflected atthe time of the puncturing operation.

Further, the pressing member 18 is disposed in the axial direction(longitudinal direction) of the catheter 12 which is in a linear state,and includes: a long main body 28 positioned above the catheter 12; anda finger hook projection 30 disposed at the main body 28, projectingaway from the main body 28 and adapted to hook a finger. The uppersurface of the main body 28 possesses an uneven shape 29, and functionsas a slip stopper at the time of operating with a finger.

The finger hook projection 30 in the illustrated present exampleprojects upward from the distal end of the main body 28. The finger hookprojection 30 may project upward from the proximal end side slightlymore than the distal end of the main body 28. That is, the finger hookprojection 30 can project upwardly from the main body 28 at a positionthat is proximal of the distal end of the main body 28 (i.e., the fingerhook projection 30 is located between the distal end of the main body 28and the middle of the main body.) Or, the finger hook projection 30 mayproject upward from the middle of the main body 28 in the longitudinaldirection (between the distal end and the proximal end) of the main body28. In the present example illustrated, the above-described pressingportion 26 is formed by the bottom portion of the distal end of the mainbody 28. The pressing portion 26 may also be formed as a projectionprojecting downward from the distal end portion of the main body 28.

The pressing portion 26 is disposed at a portion where the inner needle16 and the catheter 12 can be effectively prevented from being deflectedat the time of the puncturing operation. For example, a distance from amost distal end position of the catheter 12 to a portion pressed by thepressing portion 26 is about 8 to 60 mm, preferably, about 10 to 30 mm.

The pressing member 18 is connected to the catheter hub 14 in a mannerrotatable with respect to the catheter hub 14. As illustrated in FIG.4A, support projections 32 projecting outward are disposed on outersurfaces on both right and left sides of the catheter hub 14 in theillustrated present example. The respective support projections 32extend in a vertical direction. As illustrated in FIG. 4B, a pair ofconnection pieces 38 (right and left connection pieces 38) that eachinclude connection grooves 34 and that each face each other is disposedat a proximal end portion of the main body 28. The connection grooves 34open inward and face each other.

Each of the connection grooves 34 includes a first groove 35 for fittingand a second groove 36 for separation. The second groove 36 has a groovewidth narrower than the first groove 35, and extends in the proximal enddirection to a proximal end surface of the connection piece 38 from thegroove 35 for fitting. The second groove 36 has a groove width W2slightly larger than a width W1 of the support projection 32. Thesupport projection 32 provided at the catheter hub 14 is inserted intoeach of the first grooves 35 provided at the pressing member 18. Bythis, the pressing member 18 is supported in a rotatable manner withrespect to the catheter hub 14, using the support projection 32 as theaxis of rotation.

The pressing member 18 is configured to be displaced to a first positionlocated in the longitudinal (axial) direction of the catheter 12 (referto FIG. 7) and a second position retracted from the catheter 12 (referto FIG. 8). When the pressing member 18 is positioned at the firstposition, the pressing member 18 is positioned above the catheter 12, inaxial overlapping relation to the catheter 12, and the distal endportion of the pressing member 18 (pressing portion 26) is positionedbetween the proximal end and the distal end of the catheter 12. Further,when the pressing member 18 is positioned at the first position, thesupport projection 32 is fitted into the first groove 35. Therefore, thepressing member 18 is prevented from separating from the catheter hub14.

When the pressing member 18 is positioned at the second position, thepressing member 18 extends in a direction intersecting the longitudinaldirection of the catheter 12 (substantially vertical direction withrespect to the longitudinal direction of the catheter 12 in theillustrated present example). Further, when the pressing member 18 ispositioned at the second position, the support projection 32 and thesecond groove 36 extend in the same direction. Therefore, the pressingmember 18 can be separated from the catheter hub 14.

A constituent material from which the pressing member 18 is fabricatedis not particularly limited, and for example, may be selected from thematerials described above as examples of the constituent material of thecatheter hub 14.

The guide wire 20 is a flexible linear member to guide the catheter 12at the time of inserting the catheter 12 into the blood vessel in orderto indwell the catheter 12 in the patient. The guide wire 20 is longerthan the inner needle 16 and the catheter 12. The guide wire 20 has anouter diameter smaller than the inner diameter of the lumen 17 of theinner needle 16. When the catheter assembly 10A is in the assembledstate, the distal end of the guide wire 20 is located on the moreproximal end side than the needlepoint 16 a of the inner needle 16 is,and is positioned in the vicinity of the needlepoint 16 a in theillustrated present example. That is, in the assembled state of theassembly 10A, the distal end of the guide wire 20 is located proximallyof the needlepoint 16 a of the inner needle 16. The guide wire 20 isslidably inserted into the inner needle 16, and the distal end of theguide wire 20 can project from (distally beyond) the needlepoint 16 a.

When the catheter assembly 10A is in the assembled state, the proximalend of the guide wire 20 is located on the more proximal end side thanthe proximal end of the catheter 12 (i.e., the proximal end of the guidewire 20 is positioned proximally of the proximal end of the catheter12). The guide wire 20 has a length longer than respective lengths ofthe inner needle 16 and the catheter 12, and is, for example, about 40to 1200 mm, and preferably, set to about 100 to 700 mm.

A constituent material of which the guide wire 20 is fabricated is notparticularly limited, but for example, various kinds of metallicmaterials such as stainless steel and Ni—Ti-based alloy can be used. Theguide wire 20 can have an entire length formed of a single material suchas stainless steel or Ni—Ti-based alloy, but can be also formed ofcombination of different materials. An entire or a part of an outerperipheral surface (outer surface) of the guide wire 20 may be coatedwith a material having lubricity (PTFE, ETFE, etc., for example).

The wire operating member 22 is an operating portion to perform aninserting operation of the guide wire 20 into the blood vessel beforeperforming an inserting operation of the catheter 12 into the bloodvessel of the patient. In the present embodiment, the wire operatingmember 22 extends in the longitudinal direction of the inner needle 16and the catheter 12, and is connected to the proximal end of the guidewire 20. More specifically, as illustrated in FIG. 2, the wire operatingmember 22 includes an elongated extending portion 40 extending in thelongitudinal (axial) direction of the inner needle 16 and the catheter12, and a wire holding potion 42 provided at the lower portion at theproximal end of the extending portion 40 and is configured to hold theproximal end of the guide wire 20.

The extending portion 40 is plate-shaped, and is slidable in thelongitudinal direction on the pressing member 18. An uneven shape 41 isformed on the upper surface of the extending portion 40 at the distalend of the extending portion 40, and functions as a slip stopper at thetime of performing an operation with touch of a finger.

A cut-out portion 44 extending in the longitudinal (axial) direction ofthe extending portion 40 is formed at the extending portion 40. Thecut-out portion 44 reaches or extends to a most distal end portion ofthe extending portion 40. By providing such a cut-out portion 44, thefinger hook projection 30 is prevented from interfering with movement ofthe wire operating member 22 at the time of moving the wire operatingmember 22 in the distal end direction with respect to the pressingmember 18. Even in a state that the wire operating member 22 is moved inthe distal end direction with respect to the pressing member 18 (referto FIG. 5), it is possible to touch the finger hook projection 30 viathe cut-out portion 44. Therefore, the pressing member 18 can be easilyoperated.

In the present example illustrated, the wire operating member 22 islonger than the pressing member 18, and the distal end portion of thewire operating member 22 is positioned above the portion of the pressingmember 18 between the distal end and the proximal end of the pressingmember 18 in the assembled state. The distal end portion of the wireoperating member 22 thus axially overlaps a portion of the pressingmember 18 located between the distal end and the proximal end of thepressing member 18 in the assembled state. The wire operating member 22may have a length substantially the same as the pressing member 18, or alength shorter than the pressing member 18.

The gripping member 24 extends in the longitudinal (axial) direction ofthe inner needle 16 and the catheter 12, and possesses an elongatedshape as a whole. As illustrated in FIG. 3, the gripping member 24 isconnected to the inner needle 16 on a proximal end side of the innerneedle 16, and also houses the pressing member 18 and the wire operatingmember 22 in a manner movable in the longitudinal (axial) direction inthe assembled state. More specifically, as illustrated in FIG. 2, thegripping member 24 includes: a bottom plate 46; side walls 48, 50extending upward from both right and left sides of the bottom plate 46;and a proximal end wall 52 upstanding at the proximal end of the bottomplate 46 and connecting the right and left side walls 48, 50. The upperside and the distal end side of the gripping member 24 are open. FIGS. 1and 2 thus show that at least a portion of the gripping member 24 is aU-shaped portion in transverse cross-section, and the catheter hub 14and the proximal end of the catheter 12 are positioned in the U-shapedportion of the gripping member 24 in the assembled state of the catheterassembly before use of the catheter assembly.

A guide groove 47 is formed at center in a lateral direction on thedistal end side of the bottom plate 46, and extends in the longitudinal(axial) direction of the gripping member 24 up to a most distal end ofthe bottom plate 46. When the catheter 12 is moved in the distal enddirection with respect to the gripping member 24, the catheter 12 isguided by the guide groove 47. Therefore, the catheter 12 can be stablymoved without slipping off in the lateral direction.

The pressing member 18 and the wire operating member 22 are disposedinside the thus structured gripping member 24. The gripping member 24functions as a guide member to control movement directions of thepressing member 18 and the wire operating member 22 when the pressingmember 18 and the wire operating member 22 are moved in the distal enddirection.

A needle holder 54 that holds the proximal end portion of the innerneedle 16 is provided at the middle portion (intermediate location) inthe longitudinal (axial) direction of the gripping member 24. The innerneedle 16 and the gripping member 24 thus move together as a unit. Theneedle holder 54 is provided inside the gripping member 24 (between theright and left side walls 48, 50). As illustrated in FIG. 3, the needleholder 54 includes a holding hole 56, and the inner needle 16 ispositioned in and fixed to the holding hole 56. The needle holder 54includes an upper surface 54 a formed as a slide surface to support thewire operating member 22 in a slidable manner. When the catheterassembly 10A is in the assembled state, the catheter member 15 and thepressing member 18 are housed inside the gripping member 24 on the moredistal end side than the needle holder 54.

Thus, since the gripping member 24 holds the inner needle 16 at theneedle holder 54, when the gripping member 24 is moved in the proximalend direction relative to the catheter 12, the inner needle 16 is alsomoved in the proximal end direction relative to the catheter 12 alongwith movement of the gripping member 24. In other words, the grippingmember 24 also functions as the inner needle hub fixed to the proximalend of the inner needle 16. The catheter assembly 10A is configured sothat the wire operating member 22 simultaneously axially overlaps aproximal portion of the pressing member 18, a proximal portion of thecatheter 12, the catheter hub 14 and a proximal portion of the guidewire 20.

The catheter assembly 10A according to the present embodiment has thestructure described above, and the operation and effects of the catheterassembly 10A will be described below.

As illustrated in FIG. 1, when the catheter assembly 10A is in theassembled state (initial state), the inner needle 16 is positioned inthe catheter 12, and the needlepoint 16 a projects from the distal endof the catheter 12 by a predetermined length, and the distal end of theguide wire 20 is located inside the inner needle 16. In the puncturingoperation to puncture skin of the patient with the catheter assembly 10Ain the assembled state, the user (doctor, nurse, etc.) grips thegripping member 24 with one hand (for example, right hand). Then, whilepressing a distal end portion of the pressing member 18 with aforefinger of the mentioned one hand, the skin is punctured toward ablood vessel of a puncturing target in a manner pressing the distal endportion of the catheter assembly 10A (distal end portion of the catheter12 inserted with the inner needle 16) against the patient. Theneedlepoint punctures the skin and then the blood vessel to provideaccess to the blood vessel.

In this case, according to the present embodiment, the inner needle 16and the catheter 12 can be prevented from being deflected by pressingthe middle portion between the proximal end and the distal end of thecatheter 12 downward with the pressing member 18. In other words, in astate that the middle portion of the catheter 12 is pressed with thepressing member 18, the catheter 12 is supported by being sandwichedbetween the pressing member 18 (pressing portion 26 of the pressingmember 18) and the gripping member 24 (bottom plate 46 of the grippingmember 24). As a result, the inner needle 16 and the catheter 12 areprevented from being deflected. Therefore, the puncturing operation canbe relatively easily performed even in the case where the inner needle16 and the catheter 12 are relatively long.

Next, in a state the skin and blood vessel are punctured with the distalend portions of the inner needle 16 and the catheter 12, the wireoperating member 22 is slightly advanced in the distal end direction bytouching and slightly pushing the upper surface of the distal endportion of the wire operating member 22 with a forefinger of one handwhile keeping or maintaining the position of the gripping member 24. Bythis, the guide wire 20 is made to project from the distal end of theinner needle 16 by several millimeters. Next, the guide wire 20 is movedin the distal end direction to a maximum extent by moving the wireoperating member 22 in the distal end direction with the other hand(left hand, for example) (refer to FIG. 5). The guide wire 20 isinserted into the blood vessel along with movement of the guide wire 20in the distal end direction.

Meanwhile, as illustrated by the virtual line in FIG. 5, a middleportion in the longitudinal (axial) direction of the wire operatingmember 22 may be configured to be curved or bent in a directionseparating from the outer needle so that the middle portion of the wireoperating member 22 moves away from outer needle. In this case, the wireoperating member 22 can be bent by providing a hinge structure 58 formedof a thin portion (weakened portion) or by providing another hingestructure 58 including an axis and a bearing at the middle portion inthe longitudinal direction of the wire operating member 22. Otherwise,the wire operating member 22 can be curved by forming the wire operatingmember 22 of a flexible member.

Since the wire operating member 22 is configured to be curved or bent,the middle portion of the wire operating member 22 is bent or curvedeven in the case where the distal end portion of the wire operatingmember 22 hits a part of the patient at the time of moving the wireoperating member 22 in the distal end direction in order to insert theguide wire 20 into the blood vessel. Therefore, the wire operatingmember 22 can be prevented from interfering with the patient, andinsertion of the guide wire 20 into the blood vessel can be relativelyeasily and surely performed.

When the distal end of the guide wire 20 is inserted up to a targetposition inside the blood vessel, the pressing member 18 is subsequentlyadvanced by the forefinger of one hand by several millimeters, therebyadvancing the catheter 12 by several millimeters. Next, the pressingmember 18 is moved in the distal end direction by the other hand (referto FIG. 6), thereby inserting the distal end of the catheter 12 up tothe target position inside the blood vessel. At this point, the catheter12 follows the guide wire 20 inserted into the blood vessel beforehand,more specifically, the catheter 12 is advanced inside the blood vessel,following the guide wire 20. Therefore, the distal end of the catheter12 can be easily introduced up to the target position inside the bloodvessel.

Next, the gripping member 24 is gripped with one hand while pressing thepressing member 18 with the other hand, and the gripping member 24 ispulled in the proximal end direction. The inner needle 16 is thusremoved from the catheter 12 as illustrated in FIG. 7. After removingthe inner needle 16 from the catheter 12, the pressing member 18 may bedetached from the catheter hub 14, if necessary. In this case, asillustrated in FIG. 8, the pressing member 18 is moved to the secondposition (standing upright in a substantially vertical posture withrespect to the catheter hub 14 in the present embodiment). Next, asillustrated in FIG. 9, the pressing member 18 can be separated from thecatheter hub 14 by pulling the pressing member 18 upward. Meanwhile, thepressing member 18 may also be kept attached to the catheter hub 14after removing the inner needle 16 from the catheter 12.

Next, the connector of the infusion tube (not illustrated) is connectedto a proximal end side of the catheter member 15 from which the innerneedle 16 has been removed, and infusion material (chemical solution) isadministered from the infusion tube to the patient.

As described above, according to the catheter assembly 10A of thepresent embodiment, when the skin is punctured with the respectivedistal end portions of the inner needle 16 and the catheter 12, theinner needle 16 and the catheter 12 can be prevented from beingdeflected by pressing the middle portion between the proximal end andthe distal end of the catheter 12 downward with the pressing member 18.Therefore, the puncturing operation can be rather easily performed evenin the case where the inner needle 16 and the catheter 12 are relativelylong.

Further, after the puncturing operation, the guide wire 20 is insertedinto the blood vessel before inserting the catheter 12 into the bloodvessel. Therefore, the catheter 12 can be smoothly moved in the distalend direction along the guide wire 20. The distal end of the catheter 12can thus be rather easily introduced to a target portion along the guidewire 20 even in a blood vessel that meanders and branches.

Further, since the catheter assembly 10A includes the wire operatingmember 22 extending along the pressing member 18, the moving operationof the guide wire 20 can be fairly easily performed.

In the case of the present embodiment, the wire operating member 22 isdisposed in a manner superimposed on (axially overlapping) the pressingmember 18. According to this structure, the catheter assembly 10A can berelatively easily gripped with excellent operability at the time of thepuncturing operation and the like because the catheter assembly 10A canbe formed thin.

In the case of the present embodiment, the finger hook projection 30 isprovided at the distal end of the pressing member 18, and also thecut-out portion 44 is provided at the wire operating member 22.Therefore, the pressing member 18 can be operated by touching thepressing member 18 from above in a state that the distal end of the wireoperating member 22 is advanced beyond the distal end of the pressingmember 18 (state in FIG. 5). According to this structure, the wireoperating member 22 is prevented from interfering and the pressingmember 18 can be rather easily operated even in the state that the wireoperating member 22 is moved in the distal end direction.

In the case of the present embodiment, the catheter assembly 10Aincludes the gripping member 24 that houses the pressing member 18 andthe wire operating member 22 in a manner movable in the longitudinal(axial) direction. According to this structure, the gripping member 24can be gripped with a hand in respective operations: at the time ofpuncturing a skin with the respective distal ends of the inner needle 16and the catheter 12; at the time of moving the catheter 12 in the distalend direction when moving the guide wire 20 in the distal end direction;and at the time of pulling out the inner needle 16 from the catheter 12.Therefore, the respective operations can be easily performed.

FIGS. 10-12 illustrate a catheter assembly 10B according to a secondembodiment. Components in the catheter assembly 10B according to thesecond embodiment that provide functions and effects the same as orsimilar to components in the catheter assembly 10A according to thefirst embodiment are denoted by the same reference numerals, and adetailed description of such aspects of the catheter assembly are notrepeated.

The catheter assembly 10B includes a catheter member 15, an inner needle16, and a guide wire 20 the same as the catheter assembly 10A accordingto the first embodiment. The catheter assembly 10B differs from thecatheter assembly 10A according to the first embodiment with respect tothe structures constituting a pressing member 59, a wire operatingmember 60, and a gripping member 62. Further, the catheter assembly 10Bdiffers from the catheter assembly 10A according to the first embodimentin including an operating wire 66 and a wire housing portion 64. Adescription of these different aspects of the catheter assembly 10B isset forth next.

The pressing member 59 differs from the pressing member 18 in the firstembodiment in that the pressing member 59 does not include a finger hookprojection 30.

The wire operating member 60 extends in a longitudinal (axial) directionof the inner needle 16 and a catheter 12, and has a common point withthe wire operating member 22 of the first embodiment in that the wireoperating member 60 is displaceable in the longitudinal (axial)direction relative to the inner needle 16 and the catheter 12. The wireoperating member 60 is shorter than the wire operating member 22 in thefirst embodiment. The wire operating member 60 is disposed in a mannersuperimposed on or axially overlapping the pressing member 59, andslidable in the longitudinal direction on the pressing member 59. Adistal end portion 66 a of the operating wire 66 is connected and fixedto a proximal end portion of the wire operating member 60.

The operating wire 66 has a proximal end side (proximal end portion 66b) connected to the guide wire 20, and is a linear member to move theguide wire 20. The operating wire 66 may be shorter than the guide wire20. The portion of the guide wire 20 and the operating wire 66 that aredistal of the connected portions (i.e., the connected portions 20 b, 66b at which the guide wire 20 and the operating wire 66 are connected)are separated from each other and are not joined to each other. Aconstituent material from which the operating wire 66 is fabricated isnot particularly limited as far as the above function can be achieved,but the constituent material may be same as the guide wire 20, forexample. Preferably, the operating wire 66 is a flexible linear member.

The gripping member 62 houses the pressing member 59 and the wireoperating member 60 in a manner movable in the longitudinal direction.The gripping member 62 is shorter than a gripping member 24 in the firstembodiment. More specifically, the length on the proximal end side ofthe needle holder 54 of the gripping member 62 is shorter than that ofthe gripping member 24 of the first embodiment. A through-hole 52 a isprovided at a proximal end wall 52 of the gripping member 62. A distalend portion of the wire housing portion 64 is fixed at the through-hole52 a.

The wire housing portion 64 is a flexible tubular member having arelatively small inner diameter. The wire housing portion 64 is disposedmore proximally than the inner needle 16, and is configured to house theguide wire 20 and the operating wire 66 in a state that respectiveproximal end portions of the guide wire 20 and the operating wire 66 areaxially overlapping (in a bundled state). In other words, respectiveportions out of the guide wire 20 and the operating wire 66, which areinserted into (housed inside) the wire housing portion 64, are set inthe bundled (superimposed) state inside a lumen 65 of the wire housingportion 64. When the catheter assembly 10B is in an assembled state(assembled state), the respective proximal end portions 20 b, 66 b ofthe guide wire 20 and the operating wire 66 are housed in the wirehousing portion 64.

The catheter assembly 10B according to the present embodiment has thestructure described above, and the operations and effects of thecatheter assembly 10B are described below.

As illustrated in FIG. 10, when the catheter assembly 10B is in theassembled state, the inner needle 16 is inserted into the catheter 12,and a needlepoint 16 a projects from a distal end of the catheter 12 bya predetermined length, and a distal end of the guide wire 20 is locatedin the inner needle 16. In a puncturing operation to puncture skin of apatient with the catheter assembly 10B in such an assembled state, auser (doctor, nurse, etc.) grips the gripping member 62 with one hand.Then, while pressing a distal end portion of the pressing member 59 witha forefinger of the mentioned one hand, the skin is punctured toward ablood vessel of a puncturing target in a manner pressing the distal endportion of the catheter assembly 10B (distal end portion of the catheter12 inserted with the inner needle 16) against the patient. Theneedlepoint 16A punctures the skin and then the blood vessel to provideaccess to the blood vessel.

In this case, the middle portion between a proximal end and a distal endof the catheter 12 is sandwiched and supported between the pressingmember 59 and the gripping member 62 by pressing the middle portion ofthe catheter 12 downward with the pressing member 59. As a result, theinner needle 16 and the catheter 12 can be prevented from beingdeflected. Therefore, the puncturing operation can be easily performedeven in the case where the inner needle 16 and the catheter 12 arerelatively long.

Next, in a state that the skin and blood vessel are punctured with thedistal end portions of the inner needle 16 and the catheter 12, the wireoperating member 60 is slightly advanced in the distal end direction bytouching and slightly pushing the upper surface of a distal end portionof the wire operating member 60 with a forefinger of one hand whilekeeping or maintaining the position of the gripping member 62. The guidewire 20 is thus axially moved to project from the distal end of theinner needle 16 by several millimeters. Next, the guide wire 20 is movedin the distal end direction to a maximum extent by moving the wireoperating member 60 in the distal end direction with the other hand(refer to FIG. 13). The guide wire 20 is inserted into the blood vesselalong with movement of the guide wire 20 in the distal end direction.

In this case, since a proximal end portion of the guide wire 20 ishoused in the wire housing portion 64, the guide wire 20 is preventedfrom being deflected at the time of advancing the guide wire 20. Inother words, a portion of the guide wire 20 on the proximal side of theproximal end of the inner needle 16, which is not supported by the wirehousing portion 64, is only a relatively short portion from the proximalend of the inner needle 16 to the wire housing portion 64. Further, theguide wire 20 is flexible, but also has a certain level of rigidity tostand against bending deformation. Therefore, when force is applied inthe distal end direction from the proximal end portion 20 b of the guidewire 20 via the operating wire 66, the portion of the guide wire 20between the proximal end of the inner needle 16 and the wire housingportion 64 is prevented from being deflected by the own rigidity of theguide wire 20.

Further, according to the present embodiment, the wire housing portion64 does not become an obstacle because the flexible wire housing portion64 can be curved and prevented from interfering with the patient even inthe case where the wire housing portion 64 hits a part of the patient.In other words, the entire length of the catheter assembly 10B tends tobe elongated by including the guide wire 20, compared to a structure notincluding the guide wire 20. However, the wire housing portion 64, andthe guide wire 20 and the operating wire 66 housed inside the wirehousing portion 64, are all flexible and can be rather easily deformedwhen an external force is applied. Therefore, these components do notbecome obstacles at the time of using the catheter assembly 10B.

When the distal end of the guide wire 20 is inserted up to the targetposition inside the blood vessel, the wire operating member 60 issubsequently moved to a position deviated in a lateral direction fromabove the pressing member 59 by using the other hand as illustrated inFIG. 14. In the case of the present embodiment, the wire operatingmember 60 and the guide wire 20 are connected by the flexible operatingwire 66, and further the wire operating member 60 can be separated fromthe gripping member 62. Therefore, the wire operating member 60 can beeasily moved to a position deviated from above the pressing member 59. Asubsequent operation for the pressing member 59 can thus be easilyperformed.

Next, the pressing member 59 is advanced by several millimeters in thedistal end direction by the forefinger of one hand, thereby advancingthe catheter 12 by several millimeters. Next, the pressing member 59 ismoved in the distal end direction by the other hand as illustrated inFIG. 15. The distal end of the catheter 12 is thus inserted up to thetarget position inside the blood vessel. At this point, the catheter 12follows the guide wire 20 inserted into the blood vessel beforehand,more specifically, the catheter 12 is advanced inside the blood vessel,following the guide wire 20. Therefore, the distal end of the catheter12 can be easily introduced up to the target position inside the bloodvessel.

Next, the gripping member 62 is gripped with one hand while pressing thepressing member 59 with the other hand, and the gripping member 62 ispulled in the proximal end direction. This causes the inner needle 16 tobe removed from the catheter 12 as illustrated in FIG. 16. Afterremoving the inner needle 16 from the catheter 12, the pressing member59 may be detached from the catheter hub 14, if necessary. In this case,as illustrated in FIG. 17, the pressing member 59 is moved to a secondposition (standing upright in a substantially vertical posture withrespect to the catheter hub 14 in the present embodiment). Next, asillustrated in FIG. 18, the pressing member 59 can be separated from thecatheter hub 14 by pulling the pressing member 59 upward. It is alsopossible to keep the pressing member 59 attached to the catheter hub 14after removing the inner needle 16 from the catheter 12.

Next, the connector of the infusion tube (not illustrated) is connectedto a proximal end side of the catheter member 15 from which the innerneedle 16 has been removed, and infusion material (chemical solution) isadministered from the infusion tube to the patient.

As described above, when the skin is punctured with the respectivedistal end portions of the inner needle 16 and the catheter 12, theinner needle 16 and the catheter 12 can be prevented from beingdeflected by pressing the middle portion between the proximal end andthe distal end of the catheter 12 downward with the pressing member 59.Therefore, the puncturing operation can be relatively easily performedeven in the case where the inner needle 16 and the catheter 12 arerelatively long.

Further, after the puncturing operation, the guide wire 20 is insertedinto the blood vessel before inserting the catheter 12 into the bloodvessel. Therefore, the catheter 12 can be moved in the distal enddirection along the guide wire 20. As a result, the distal end of thecatheter 12 can be rather easily introduced to a target portion alongthe guide wire 20 even in the blood vessel having meandering andbranching.

Further, since the portion on the proximal end side of the guide wire 20is housed in the wire housing portion 64, the guide wire 20 on the moreproximal end side than the inner needle 16 is prevented from beingdeflected at the time of advancing the guide wire 20.

Further, the flexible wire housing portion 64 can be curved andprevented from interfering with the patient even in the case where thewire housing portion 64 hits a part of the patient. Therefore, the wirehousing portion 64 does not become an obstacle.

Further, in the case of the present embodiment, the wire operatingmember 60 can be moved to a position deviated in the lateral directionfrom above the pressing member 59 in a state that the wire operatingmember 60 is moved from an initial position in the distal end direction(refer to FIG. 14). According to this structure, the wire operatingmember 60 is separated from the pressing member 59 after moving the wireoperating member 60 in the distal end direction in order to insert theguide wire 20 into the blood vessel. As a result, the wire operatingmember 60 does not become an obstacle at the time of easily operatingthe pressing member 59.

It is to be understood that the respective components in the secondembodiment that are the same as those in the first embodiment canachieve the functions and effects the same as or similar to thefunctions and effects brought by the respective components of the firstembodiments.

The detailed description above describes embodiments of a catheterassembly representing examples of the inventive catheter assemblydisclosed here. The invention is not limited, however, to the preciseembodiments and variations described. Various changes, modifications andequivalents can be effected by one skilled in the art without departingfrom the spirit and scope of the invention as defined in theaccompanying claims. It is expressly intended that all such changes,modifications and equivalents which fall within the scope of the claimsare embraced by the claims.

What is claimed is:
 1. A catheter assembly comprising: a catheterpossessing a distal end, a proximal end and a proximal end portion; acatheter hub fixed to the proximal end portion of the catheter, thecatheter hub possessing a proximal-most end; a hollow inner needlepositioned inside the catheter and removable from inside the catheter,the needle possessing a distal end, and the needle including aneedlepoint at the distal end of the needle; a gripping member connectedto a proximal portion of the inner needle and extending in alongitudinal direction; a catheter operating member connected to thecatheter hub and movable in the longitudinal direction relative to theinner needle, the catheter operating member including an operatingportion; the operating portion of the catheter operating memberpossessing a part to which a force is applied by a user to move thecatheter relative to the inner needle from a position in which adistal-most end of the catheter is positioned proximal to theneedlepoint to a position in which the distal-most end of the catheteris positioned distal to the needlepoint; a guide wire slidablypositioned in the inner needle and possessing a distal end, the guidewire possessing a length longer than the inner needle and longer thanthe catheter, the guide wire being configured so that the distal end ofthe guide wire projects distally beyond the needlepoint during use ofthe catheter assembly; a wire operating member connected to the guidewire so that movement of the wire operating member results in movementof the guide wire, the wire operating member being movable in thelongitudinal direction relative to the inner needle and the catheter,the wire operating member including an operating portion; the wireoperating member that moves together with the guide wire possessing adistal-most end that axially overlaps a part of the catheter operatingmember when the distal-most end of the catheter is positioned proximalof the needlepoint before use of the catheter assembly; the operatingportion of the wire operating member possessing a part to which a forceis applied by the user to move the guide wire relative to the catheterand the inner needle; and the catheter operating member being configuredto press a portion of the catheter between the proximal end of thecatheter and the distal end of the catheter when the user presses on thecatheter operating member while puncturing a living body with theneedlepoint.
 2. The catheter assembly according to claim 1, wherein thecatheter operating member includes a main body section that is removablyconnected to the catheter hub.
 3. The catheter assembly according toclaim 2, wherein the main body section of the catheter operating memberpossesses an elongated configuration.
 4. The catheter assembly accordingto claim 2, wherein the part of the operating portion of the catheteroperating member to which the force is applied includes a projectiongrippable by a hand of the user to advance the catheter, the projectionbeing upstanding relative to the main body section so that theprojection projects away from the main body section.
 5. The catheterassembly according to claim 1, wherein the part of the operating portionof the catheter operating member to which the force is applied includesa projection that projects from a main body section mounted on thecatheter hub.
 6. The catheter assembly according to claim 1, wherein theguide wire operating member axially overlaps the catheter operatingmember in the assembled state of the catheter assembly before use of thecatheter assembly.
 7. The catheter assembly according to claim 6,wherein the catheter operating member includes a main body sectionconnected to the catheter hub, the operating portion of the guide wireoperating member overlying the main body section of the catheteroperating member.
 8. The catheter assembly according to claim 7, whereinthe guide wire operating member is slidable in the longitudinaldirection relative to the main body section of the catheter operatingmember.
 9. The catheter assembly according to claim 1, wherein the guidewire operating member simultaneously axially overlaps at least a portionof the catheter operating member, at least a portion of the catheterhub, at least a portion of the inner needle and at least a portion ofthe guide wire in the assembled state of the catheter assembly beforeuse of the catheter assembly.
 10. The catheter assembly according toclaim 1, wherein at least a portion of the gripping member is a U-shapedportion possessing a U-shape in transverse cross-section, the catheterhub and the proximal end of the catheter being positioned in theU-shaped portion of the gripping member in the assembled state of thecatheter assembly before use of the catheter assembly.
 11. The catheterassembly according to claim 10, wherein the U-shaped portion of thegripping member includes two opposed wall sections; the catheter hub andthe proximal end of the catheter being positioned between the twoopposed wall sections.
 12. The catheter assembly according to claim 1,wherein the gripping member possesses a distal end portion provided witha guide groove, the catheter being positioned in the guide groove. 13.The catheter assembly according to claim 1, wherein the catheter hubpossesses an outer surface, and the catheter operating member includes amain body section that is removably connected to the outer surface ofthe catheter hub.
 14. The catheter assembly according to claim 13,wherein the main body section includes two connection pieces that areremovably connected to the outer surface of the catheter hub.
 15. Thecatheter assembly according to claim 14, wherein the catheter hub ispositioned between the two connection pieces in the assembled state ofthe catheter assembly before use of the catheter assembly.
 16. Thecatheter assembly according to claim 1, wherein the distal end portionof the operating portion of the wire operating member to which the forceis applied by the user is positioned distal of the proximal-most end ofthe catheter hub in an assembled state of the catheter assembly beforeuse of the catheter assembly.